Featured Pharma Online Editorial
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Risk Tool Selection With ICH Q9(R1) In Mind
9/19/2023
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
9/14/2023
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture
9/13/2023
Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern.
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An Overview Of The 9 FDA Special Designations For Pipeline Drugs
9/8/2023
The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. Some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. What scenarios or drugs/therapies are best suited for each?
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5 Best Practices For Responding To FDA Form 483 Inspection Observations
9/1/2023
How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this 5-step action plan to make sure the findings are properly addressed.
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Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi
8/24/2023
In May 2023, the Supreme Court issued a ruling on the Section 112 enablement requirement for patents in Amgen v. Sanofi. What does this mean for patent claims involving artificial intelligence (AI) going forward? These Haynes Boone attorneys explain.
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Vendor/Supplier Management To Maintain A Drug’s Safety Profile In End-To-End Supply Chain Planning
8/17/2023
FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.
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FDA Issues Second DSCSA Warning Letter — What Does This Mean?
8/16/2023
In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.
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CGMP Requirements For Automated Facility Monitoring Systems
8/15/2023
To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.
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Agile Software Development In Bio/Pharma & Medical Devices, Part 3
7/25/2023
Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.